Medical Devices

Medical Device Regulatory Consulting: International development and marketing of medical devices requires expert level navigation to prevent bottlenecks and minimize risk.  RJR Consulting, Inc. specializes in providing this advanced regulatory consulting expertise to the Medical Device industry. We have decades of experience in the following areas related to the medical device industry:

Clinical product development
  • Medical device strategy development
  • Assistance with creation of product development plan
  • Development of standard operating procedures
  • Development of clinical and non-clinical trial protocols
Global regulatory affairs support
  • Training on global regulatory compliance for medical devices
  • Authorized representative in the United States, Canada, European Union (EU), Latin America and Southeast Asia
  • Clinical Research Organization (CRO) management
  • In Vitro Diagnostic device evaluations
  • Provide regulatory surveillance updates
  • Global Regulatory Intelligence for licensing, registrations, renewals
  • Medical Device Safety Reporting and Support Call-in Center
  • Partner identification for contract manufacturers and distributors
  • Manufacturing Related Quality Support: Process validation, cleaning validation, equipment validation and technology transfer
International regulatory documentation submissions including but not limited to:
  • Pre-Market Approval (PMA)
  • Clinical trial dossiers
  • FDA 510(k) submissions
  • Notified Body Assistance
  • Technical Files
  • License renewals including registrations, certifications and product labeling
  • Investigational Device Exemption (IDE) applications
  • CE Marking for Medical Devices
Quality Assurance, Auditing & Inspections
  • Medical Device mock audits
  • Assistance with GMP inspections
  • ISO compliance auditing
  • Risk management auditing
  • Evaluation of quality systems and processes
  • Establishment of a compliance management system

Case Studies

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